Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and effectiveness of the Corheart 6 left ventricular assist system in providing mechanical support for blood circulation in patients with advanced left ventricular heart failure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corheart 6 LVAS | Experimental | The Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced left ventricular heart failure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corheart 6 LVAS | Device | Implantation of left ventricular assist device for mechanical circulatory support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Survival Rate without Disabling Stroke | Composite survival is defined as meeting one of the following conditions:
| 6 months after device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Survival Rate without Disabling Stroke | 24 months after device implantation | |
| Composite Survival Rate | 5-year composite survival rate after implantation | 5 years after device implantation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leon Lai | Contact | +86 755 23225941 | laishengfeng@coretechmed.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bridge Heart Transplantation Rate | 6 months, 12 months, 24 months, 5 years after surgery |
| Device Removal Rate | Device removal rate due to recovery of cardiac function | 6 months, 12 months, 24 months, 5 years after surgery |
| NYHA Functional Class assessed using the New York Heart Association (NYHA) Functional Classification (Class I-IV) | The outcome measure will be assessed using the New York Heart Association (NYHA) Functional Classification, a clinician-assessed four-class scale (Class I-IV) that categorizes the severity of heart failure symptoms based on the patient's physical activity limitations and symptoms. | baseline, 6 months, 12 months, 24 months, 5 years after surgery |
| KCCQ Questionnaire | Kansas Cardiomyopathy Questionnaire (KCCQ) | baseline, 6 months, 12 months, 24 months, 5 years after surgery |
| Anxiety assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7) | Anxiety will be assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7), a validated 7-item patient-reported questionnaire with scores ranging from 0 to 21, where higher scores indicate more severe anxiety symptoms. | baseline, 6 months, 12 months, 24 months, 5 years after surgery |
| Depression assessed using the Patient Health Questionnaire-9 (PHQ-9) | Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item patient-reported questionnaire with scores ranging from 0 to 27, where higher scores indicate more severe depressive symptoms. | baseline, 6 months, 12 months, 24 months, 5 years after surgery |
| Adverse Events | 6 months, 12 months, 24 months, 5 years after surgery |
| Device Failure Rate | 6 months, 12 months, 24 months, 5 years after surgery |